BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2350925 · Received November 29, 2011

    Report

    Report Number
    2939301-2011-11575
    Event Type
    Injury
    Date Received
    November 29, 2011
    Report Date
    November 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510 (K) # IS K0535290.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (02/15/2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 INACCURATE READINGS ON THEIR ONE TOUCH ULTRA 2 METER. THE PATENT MENTIONED THAT THE ALLEGED ISSUE BEGAN AROUND (B)(6) 2011. AT AN UNSPECIFIED DATE AND TIME AROUND THE WEEK OF (B)(6) 2011, THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 150 MG/DL AND INCREASED THEIR DOSAGE OF MEDICATION (1 EXTRA PILL OF GLUCOPHAGE 500). SOMETIME LATER, THE PATIENT DEVELOPED SYMPTOMS OF COLD SWEAT AND FEELING DIZZY. THE PATIENT WENT TO THE ER AND WAS TESTED ON THE PHYSICIAN'S METER AND OBTAINED A 85 MG/DL AND WAS TREATED WITH FOOD/DRINK AND WAS TESTED AFTER TREATMENT AND OBTAINED A 94 MG/DL. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS USING EXPIRED TESTING SUPPLIES. USING EXPIRED TESTING SUPPLIES CAN LEAD TO FALSE BLOOD GLUCOSE READINGS. THE PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, THEY TOOK AN INCREASE DOSAGE OF MEDICATION AND AT AN UNSPECIFIED TIME LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2897760

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R